Stress Urinary IncontinencePhase 2NCT06247241
A Phase 2a Study To Evaluate VMB-100 In Females With Stress Urinary Incontinence
A Phase 2 study testing VMB-100 in people with Stress Urinary Incontinence, run by Versameb AG.
Trial summary
The study drug VMB-100 is an mRNA encoding for IGF-1. It is administered by injection into the urethra sphincter, and taken up by the muscle cells. The IGF-1 acts to promote muscle regeneration in the sphincter, which is expected to improve the function of the sphincter and thereby alleviate incontinence (urinary… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- VMB-100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Apr 2029
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Main inclusion criteria:
- Pre- or peri-menopausal female subject between 18 and 55 years of age
- Body mass index (BMI) of 19 to 35 kg/m2
- Active SUI of moderate severity for at least 6 consecutive months documented in medical history
- Refractory to standard of care measures
- Must not be pregnant, lactating, or actively trying to become pregnant.
Main exclusion criteria:
- Any concurrent condition or any clinically significant abnormality at Screening which in the opinion of the Investigator may affect the interpretation of safety or efficacy data or which otherwise contradicts participation in a clinical study with VMB-100
- Unwilling to undergo transvaginal sonography or cystoscopy
- Urodynamic detrusor overactivity
- History of urinary urge incontinence of neurogenic etiology.
- History of or planning for pelvic radiation.
- History of use of any bulking agent or Botox to treat SUI in the past 12 month.
- History of urethral sling, anterior prolapse repair, and/or other SUI procedures or surgical procedures affecting continence.
- Taking any medications that are known to have an effect on urinary continence or medications that may exacerbate incontinence
About this study
Official title: A Phase 2a, Open-Label, First-In-Human, Two-Part, Single And Multiple Ascending Dose Study To Evaluate The Safety, Tolerability, And Efficacy Of VMB-100 In Female Subjects With Moderate Stress Urinary Incontinence
The study drug VMB-100 is an mRNA encoding for IGF-1. It is administered by injection into the urethra sphincter, and taken up by the muscle cells. The IGF-1 acts to promote muscle regeneration in the sphincter, which is expected to improve the function of the sphincter and thereby alleviate incontinence (urinary leakage).
Read the detailed description
Versameb AG (Sponsor) is developing VMB-100 for the treatment of stress urinary incontinence (SUI), and mixed urinary incontinence (MUI) with a predominant stress component, a common and debilitating condition that significantly impacts quality of life, and for which there are currently no approved pharmacological therapies available in the US.
The drug substance of VMB-100 is a mRNA encoding human insulin-like growth factor-1 (IGF-1). VMB-100 is administered as a transurethral injection into the urinary sphincter muscle. The injected mRNA is taken up by the muscle tissue cells and serves as a template for the translation of the protein IGF-1.
Insulin-like growth factor-1 is secreted into the extracellular space, where it acts to promote muscle regeneration of the urinary sphincter via auto- and paracrine activation of downstream pathways in a localized manner.
The current understanding in urology is that reduced maximum urethral closure pressure (MUCP) is the factor most strongly associated with SUI. This implies that improving function of the closure muscles would have therapeutic merit in both SUI as well as MUI with a predominant stress component.
No treatment which restores the physiology (regenerates the urinary sphincter muscle) is currently available. Given IGF-1's role in regenerating/maintaining muscle tissue women with SUI may benefit from a localized increase in IGF-1 levels in the urinary sphincter to regenerate muscle and restore sphincter function, thus alleviating the incontinence.
- Conditions
- Stress Urinary Incontinence
- Being tested
- VMB-100
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VMB-100Drug
VMB-100 is administered as intrasphincteric injection in the urethra sphincter
| Study group | Role | What they receive |
|---|---|---|
| VMB-100 administration | Experimental | intrasphincteric injection of VMB-100 in the urethra sphincter Receives: Drug: VMB-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety following VMB-100 administration
Adverse Events (AEs)
Measured: from baseline/preinjection through study completion (est average 1 year)
Safety following VMB-100 administration
Treatment Emergent Adverse Events (TEAEs)
Measured: immediately after the intervention through study completion (est average 1 year)
Safety following VMB-100 administration
Adverse Events of Special Interest (AESIs)
Measured: immediately after the intervention through study completion (est average 1 year)
Tolerability of VMB-100 injection, pain
measurement of pain by Visual Analogue Scale (0-10, where 0 is no pain and 10 is the worst pain)
Measured: periprocedurally
Vital signs following VMB-100 administration
heart rate, blood pressure, respiratory rate, body temperature
Measured: from baseline/preinjection through study completion (est average 1 year)
12-lead ECG following VMB-100 administration
P-wave, QRS complex, QTc prolongation
Measured: from baseline/preinjection through study completion (est average 1 year)
Clinical laboratory measurements following VMB-100 administration
change in hematology parameters ( proportion of subjects)
Measured: from baseline/preinjection through study completion (est average 1 year)
Clinical laboratory measurements following VMB-100 administration
change in biochemistry parameters (proportion of subjects)
Measured: from baseline/preinjection through study completion (est average 1 year)
Clinical laboratory measurements following VMB-100 administration
change in urinalysis (proportion of subjects)
Measured: from baseline/preinjection through study completion (est average 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study startSep 2025 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionApr 2029 (estimated)
Why it stopped: The study has not enrolled study participants, and will not start enrolling, due to insufficient funding and is withdrawn from .
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Single and multiple ascending dose
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versameb AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247241
- Sponsor's protocol ID
- VMB-100-U222
- Status last verified
- Mar 2025
- First submitted
- 19 Jan 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open-Label, First-In-Human, Two-Part, Single And Multiple Ascending Dose Study To Evaluate The Safety, Tolerability, And Efficacy Of VMB-100 In Female Subjects With Moderate Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06247241
- Acronym / sponsor ID
- VMB-100-U222
- Conditions
- Stress Urinary Incontinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study has not enrolled study participants, and will not start enrolling, due to insufficient funding and is withdrawn from .
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Versameb AGIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- Sep 2025 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study drug VMB-100 is an mRNA encoding for IGF-1. It is administered by injection into the urethra sphincter, and taken up by the muscle cells. The IGF-1 acts to promote muscle regeneration in the sphincter, which is expected to improve the function of the sphincter and thereby alleviate incontinence (urinary leakage).
Detailed description
Versameb AG (Sponsor) is developing VMB-100 for the treatment of stress urinary incontinence (SUI), and mixed urinary incontinence (MUI) with a predominant stress component, a common and debilitating condition that significantly impacts quality of life, and for which there are currently no approved pharmacological therapies available in the US.
The drug substance of VMB-100 is a mRNA encoding human insulin-like growth factor-1 (IGF-1). VMB-100 is administered as a transurethral injection into the urinary sphincter muscle. The injected mRNA is taken up by the muscle tissue cells and serves as a template for the translation of the protein IGF-1.
Insulin-like growth factor-1 is secreted into the extracellular space, where it acts to promote muscle regeneration of the urinary sphincter via auto- and paracrine activation of downstream pathways in a localized manner.
The current understanding in urology is that reduced maximum urethral closure pressure (MUCP) is the factor most strongly associated with SUI. This implies that improving function of the closure muscles would have therapeutic merit in both SUI as well as MUI with a predominant stress component.
No treatment which restores the physiology (regenerates the urinary sphincter muscle) is currently available. Given IGF-1's role in regenerating/maintaining muscle tissue women with SUI may benefit from a localized increase in IGF-1 levels in the urinary sphincter to regenerate muscle and restore sphincter function, thus alleviating the incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single and multiple ascending dose
| Arm | Type | Receives |
|---|---|---|
| VMB-100 administration | Experimental | Drug: VMB-100intrasphincteric injection of VMB-100 in the urethra sphincter |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VMB-100VMB-100 is administered as intrasphincteric injection in the urethra sphincter | Drug | VMB-100 administration |
Primary outcome
Safety following VMB-100 administration
Time frame: from baseline/preinjection through study completion (est average 1 year)
Adverse Events (AEs)
Safety following VMB-100 administration
Time frame: immediately after the intervention through study completion (est average 1 year)
Treatment Emergent Adverse Events (TEAEs)
Safety following VMB-100 administration
Time frame: immediately after the intervention through study completion (est average 1 year)
Adverse Events of Special Interest (AESIs)
Tolerability of VMB-100 injection, pain
Time frame: periprocedurally
measurement of pain by Visual Analogue Scale (0-10, where 0 is no pain and 10 is the worst pain)
Vital signs following VMB-100 administration
Time frame: from baseline/preinjection through study completion (est average 1 year)
heart rate, blood pressure, respiratory rate, body temperature
12-lead ECG following VMB-100 administration
Time frame: from baseline/preinjection through study completion (est average 1 year)
P-wave, QRS complex, QTc prolongation
Clinical laboratory measurements following VMB-100 administration
Time frame: from baseline/preinjection through study completion (est average 1 year)
change in hematology parameters ( proportion of subjects)
Clinical laboratory measurements following VMB-100 administration
Time frame: from baseline/preinjection through study completion (est average 1 year)
change in biochemistry parameters (proportion of subjects)
Clinical laboratory measurements following VMB-100 administration
Time frame: from baseline/preinjection through study completion (est average 1 year)
change in urinalysis (proportion of subjects)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
Related trials for Stress Urinary Incontinence
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VMB-100 in people with Stress Urinary Incontinence, run by Versameb AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety following VMB-100 administration (time frame: from baseline/preinjection through study completion (est average 1 year)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.